A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers

A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02910635

Enrollment

Registered

2016-09-22

Start date

2016-09-19

Completion date

2016-12-20

Last updated

2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormalities, Cardiovascular

Keywords

Thorough QTc, Therapeutic dose, supra therapeutic dose

Brief summary

The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.

Interventions

DRUGVolanesorsen

ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial

DRUGMoxifloxacin

Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Must have given written informed consent and be able to comply with all study requirements * Males and females aged 18-55 at the time of informed consent * Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method * Males must be surgically sterile, abstinent or using an acceptable contraceptive method * The subject has a BMI of 19 to 32 kg/m\^2 inclusive * Consumption of nicotine or nicotine-containing products for at least 6 months before Screening

Exclusion criteria

* History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia * Abnormal screening ECG * Use of concomitant medications unless authorized by the Sponsor Medical Monitor * Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B * Treatment with another Study Drug, biological agent, or device within one-month of Screening * Tests positive for drugs of abuse or cotinine * Considered unsuitable for inclusion by the Principal Investigator

Design outcomes

Primary

Measure	Time frame	Description
Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)	24 Hours	ECG monitoring up to 24 hours post dose

Secondary

Measure	Time frame	Description
Placebo corrected change from baseline heart rate (HR, PR and QRS)	24 Hours	ECG monitoring 24 hours post dose

Other

Measure	Time frame	Description
Volanesorse plasma pharmacokinetics (PK)	0 to 24 hours	Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026